Neurovascular devices company Rapid Medical revealed on Tuesday the receipt of US FDA clearance for the Comaneci device under the new temporary coil embolization assist devices category.
The company added that the Comaneci device, which is the first and only device in a new temporary coil embolization assist devices category, is the first-ever adjustable, fully-visible aneurysm remodelling device. It acts as a temporary bridge used to aid in the coiling processes while minimising the risk of coil protrusion or prolapse.
According to the company, the Comaneci device is the only temporary coiling assist device that does not require parent vessel occlusion during coiling procedure or the need for long-term antiplatelet medication in case of permanent stenting. It is the only non-vessel-occluding temporary intracranial coiling embolization assist device.
To date, the Comaneci have been successfully used in about 3,000 procedures outside the US, concluded the company.
Crossject advances paediatric development of ZEPIZURE Junior for epilepsy crisis management
Creo Medical secures FDA clearance for SpydrBlade Flex in US market
Tissue Regenix secures CE and UKCA certifications for OrthoPure XT
Terumo Corporation expands stroke portfolio in EMEA with SOFIA Flow 88 catheter launch
Crossject advances ZENEO manufacturing with scalable aseptic filling module ahead of product rollout
ZYLOX Unicorn Vascular Closure Device approved in Indonesia
Mindray unveils BeneVision V Series at Euroanaesthesia 2025, advancing precision monitoring
Unicon Pharma and VRR Life Sciences partner support digital transformation in life sciences
Median Technologies submits 510(k) application for eyonis LCS lung cancer screening software